Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)

MDA Edge; San Juan (PR); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in IT Services is seeking a Validation Lead Engineer to oversee validation for major capital automation projects. The ideal candidate should have extensive experience in validation, compliance, and familiarity with SCADA and SAP systems, preferably in the medical device industry. Responsibilities include leading validation activities, developing protocols, and ensuring regulatory compliance.

Qualifications

• Minimum 5 years of experience leading validation of major capital automation projects.
• Strong knowledge of validation lifecycle management including IQ, OQ, PQ.
• Proven expertise in Computer System Validation (CSV).

Responsibilities

• Lead validation activities for major capital automation projects.
• Develop and execute validation protocols including IQ, OQ, and PQ.
• Ensure compliance with GxP guidelines and regulatory standards.

Skills

Validation Lifecycle Management

Technical Writing

Problem Solving

Tools

SCADA

SAP

Job description

Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)

Validation and CSV Lead Engineer (Validation Lead - Capital Automation Projects)

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This range is provided by MDA Edge. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$51.00/hr - $51.00/hr

Job Summary: We are seeking an experienced Validation Lead to oversee the validation of major capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with SCADA and SAP systems. A background in the medical device industry is preferred.
Key Responsibilities:

• Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.
• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure adherence to GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
• Maintain compliance with regulatory standards, including FDA 21 CFR Part 11, ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).
• Oversee Computer System Validation (CSV) processes, including risk-based validation, system integration, interface testing, and data integrity assessments.
• Collaborate with cross-functional teams to validate automation systems, including SCADA and SAP.
• Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.
• Ensure compliance with regulatory requirements specific to the medical device industry.

Required Qualifications:

• Minimum 5 years of experience leading the validation of major capital automation projects.
• 4-7 years of experience in the medical device industry and associated regulations.
• Strong knowledge of validation lifecycle management, including IQ, OQ, PQ, FAT, and SAT.
• Proven expertise in Computer System Validation (CSV), including software testing, system integration, and documentation.
• Familiarity with SCADA and SAP for system validation.
• Excellent technical writing and documentation skills.
• Ability to work in a regulated environment and ensure compliance with industry standards.

Preferred Qualifications:

• Experience in medical device industry validation.
• In-depth understanding of risk-based validation methodologies.
• Strong problem-solving and analytical skills.
• Ability to lead and mentor teams in validation activities.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  IT Services and IT Consulting

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